TuoXin TianCheng's B7-H3-Targeted CAR-T Therapy TX103 Receives FDA IND Approval for Malignant Glioma

Oct 03, 2023 08:00 CST Updated 08:00

Tcelltech

Developer of Immuno-oncology and Cell Therapy Drugs

Tcelltech

Tumor Drug R&D and Production

▎WuXi AppTec Content Team Report

On September 30, Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. and its U.S.-based Tcelltech company announced that the Investigational New Drug (IND) application for their TX103 CAR-T cell therapy has been approved by the U.S. FDA.For treatmentMalignant Glioma。TX103 is a CAR-T cell drug targeting B7-H3., which received FDA orphan drug designation this June for the treatment of malignant glioma.

Malignant gliomas have a high degree of malignancy, are extremely prone to recurrence after surgery, and lack effective treatment options upon recurrence, resulting in low survival rates and poor prognosis, representing a significant unmet medical need. The presence of the blood-brain barrier and the "immune-privileged" nature of the central nervous system pose important challenges for drug therapy. CAR-T cells, as a form of living immunotherapy, offer unique advantages in the treatment of glioblastoma.

According to the press release from Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd., TX103 is a CAR-T cell therapy targeting B7-H3. It has demonstrated promising safety and efficacy signals in early clinical trials for the treatment of recurrent malignant glioma. In gliomas, the expression of B7-H3 is positively correlated with the grade of the glioma; high-grade gliomas exhibit high B7-H3 expression, while low-grade or normal brain tissues show low or no B7-H3 expression.After B7-H3 is highly expressed in tumor cells, it can serve as an immune checkpoint to help tumor cells evade immunity while endowing them with a more aggressive phenotype. Therefore, high B7-H3 expression is associated with tumor invasiveness and poor prognosis.

Public information shows that Tcelltech is a clinical-stage innovative biopharmaceutical company focused on developing T-cell immunotherapy products, founded by pioneers in tumor immunology.Professor Lieping Chenand Immunocyte Therapy ExpertProfessor Gangxiong HuangCo-founded. The company is committed to the mission of research and innovation, focusing on developing innovative technologies and drugs for cancer immunotherapy and immune cell therapy.

References:

[1] Tcelltech's CAR-T Cells Receive U.S. FDA IND Approval. Retrieved Oct 1, 2023, from https://mp.weixin.qq.com/s/Yz7ZHD9bct3G1h7iXHSo_g

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